ASTM_F_2888_-_13.pdf

Designation:F288813Standard Test Method forPlatelet Leukocyte CountAn In-Vitro Measure forHemocompatibility Assessment of Cardiovascular Materials1This standard is issued under the fixed designation F2888;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This test method assists in the evaluation of cardiovas-cular device materials for their ability to induce thrombusformation.Thrombus formation is assessed by means of areduction in human platelets and leukocytes when consumedby thrombus after activation on the material surface.This assaymay be part of the hemocompatibility evaluation for devicesand materials contacting human blood,as per ANSI/AAMI/ISO 109934.See also Test Method F2382.1.2 All safety policies and practices shall be observedduring the performance of this test method.All human bloodand any materials that had contact with human blood shall bebagged in a biohazard bag,properly labeled as the contents,and disposed of by appropriate means.1.3 The human blood should be handled at Biosafety Level2 as recommended in the Centers for Disease Control/NationalInstitutes of Health Manual Biosafety in MicrobiologicalLaboratories.The human blood donor must have tested nega-tive for Hepatitis B(HBV)and Human Immunodeficiency(HIV)viruses.The blood should be treated like any patientblood in using universal precautions.1.4 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.5 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.Some specifichazards statements are given in Section 7 on Hazards.2.Referenced Documents2.1 ASTM Standards:2F2382 Test Method forAssessment of Intravascular MedicalDevice Materials on Partial Thromboplastin Time(PTT)2.2 Other Standards:ANSI/AAMI/ISO 109934 Biological Evaluation of Medi-cal DevicesPart 4:Selection of Tests for Interactionswith Blood3Centers for Disease Control/National Institutes of HealthManual Biosafety in Microbiological Laboratories,19933.Summary of Test Method3.1 This test method identifies materials which are capableof activating blood platelets and leukocytes on their surfacewhen exposed to freshly drawn human blood and causing theformation of thrombi on the material surface.A significantdecrease in the number of platelets and leukocytes whencounted by a blood analyzer is an indication of these cellsbeing entrapped in thrombi.The materials are exposed to bloodimmediately after the blood is drawn with anticoagulant.Another anticoagulant is added at the appropriate time(onehour)to stop the reaction.Different blood analyzers may beused.4.Significance and Use4.1 The purpose of this test method is to determine ifmedical materials exposed to human whole blood will ad-versely affect the platelet and leukocyte counts in whole blood.A large number of platelets and leukocytes as part of thrombiadhering to the material will be reflected by a decrease in theircounts in blood.Thrombogenic materials should not be used1This test method is under the jurisdiction ofASTM Committee F04 on Medicaland Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.16 on Biocompatibility Test Methods.Current edition approved Feb.15,2013.Published March 2013.DOI:10.1520/F288813.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 for cardiovascular medical devices,unless the purpose of thedevice is to promote thrombosis.5.Interferences5.1 There is potential for interference if the materials of thetest tubes used are thrombogenic(for example,glass tubes).Therefore,polyethylene or polypropylene tubes should beused.6.Apparatus6.1 Hematology analyzer capable of determination of acomplete blood count.6.2 Polypropylene test tubes with caps.6.3 Commercial blood collection tubes containing 3.2%,0.105 M sodium citrate.6.4 Agitating water bath/incubator,37 6 2C.6.5 Pipettes and tips(non-glass).7.Reagents and Materials7.1 Cell count controls suitable for hematology analyzer.7.2 Fresh whole human blood.7.3 EDTA(ethylenediaminetetraacetic acid),500 mM.7.4 Saline,optional.7.5 Positive reference control material(for example,naturalrubber lat